Guide: What documentation to send to your PV consultants in 2025

As a marketing authorisation holder (MAH), you may delegate pharmacovigilance activities to a PV service provider (vendor) such as PharmAdvice. However, as you retain full responsibility for these activities you must keep oversight of all PV activities and inform your PV service provider of all relevant PV matters.

In this article, you will find a list of the most common ongoing and annual pharmacovigilance activities and the documentation you should provide for each activity.

Your pharmacovigilance consultant will keep you informed of the due dates and any additional input needed.

Ongoing activities

If you have hired a PV service provider, you must be prepared to keep them informed of your pharmacovigilance activities throughout the year. Depending on your outsourcing model, this includes but is not limited to information about the following activities:

• Approvals of new medicinal products

• Updates to or plans to update product information (SmPC, PL)

• Recalls and product availability issues

• Adverse event reports received by you

• Any updates of your SOPs as listed in the PSMF

• Any other changes requiring amendments to the PSMF

• Status on PV training in your company

• Any safety-related requests you receive from health authorities

• Any additional risk management activities for your product
  

Below is additional information on the most commonly needed items.

New product approvals or updates to the summaries of product characteristics (SmPC)

As the MAH, you are required to keep all information about your EU-approved medicinal products updated in the article 57 database (XEVMPD.

For new products, you have 15 calendar days to upload the information. For updates, you must revise the information within 30 calendar days. Your PV service provider can do this for you. Remember to inform them without delay.

From a patient safety point of view, it is crucial that you inform your PV service provider (not least the QPPV) of all amendments to or plans to amend the SmPC for a product, especially when amendments are made to section 4 (4.1-4.9).

Adverse event reports

Safety information can come to you from various sources (email, phone, medical information queries, social media, market research etc). Check your various publically available media and mailboxes daily and document these checks.

In the event of you receiving an adverse event report or other safety-related information (such as exposure during pregnancy), you must inform your assigned PV service provider immediately.

Also make sure that you have standard operational procedures (SOP) and training in place for handling and reporting such information. Your PV service provider can advise you on this.

Pharmacovigilance System Master File (PSMF)

As the MAH, it is your responsibility to ensure that the pharmacovigilance system master file (PSMF) is up to date, even when you delegate the task.

If the competent authorities request to see the PSMF, you have seven days to comply. This is why we strongly recommend that you inform your PV service provider continually of changes that may require PSMF updates rather than wait for a formally scheduled periodic PSMF update.

This includes the following changes:

• Updates to your organisation (new organisation chart, new person responsible for pharmacovigilance at your company)

• Updates to partner setup (agreements and contracts)

• Updated information and contact details for safety data contact persons

• Updated information on computerised systems and databases for handling safety data

• Updates to PV SOPs and Working Instructions and any general quality system procedures that are included in the PSMF list of procedures

• Planned and/or conducted audits involving PV topics and conducted by you as the MAH

• Updates to your list of approved company products and marketing authorisations covered by the PV system.

Activities and deliverables during the year

Pharmacovigilance System Master File (PSMF)

The pharmacovigilance system master file (PSMF) must be kept up to date. This means regular updates must be planned – and you must be able to update and submit the PSMF to the competent authorities on request within seven calendar.

For regular PSMF updates, your PV service provider typically initiates the activity and sends you a draft for review, inputs and response to vendor queries. To optimise the process and prepare for any ad hoc updates, we recommend the draft be continually updated, and it is important that you provide any amendments at your end on an ongoing basis.

Documentation of the MAH’s pharmacovigilance activities

The QPPV is legally required to maintain oversight of PV activities at the MAH’s organisation.

For your QPPV to be able to do this, you must maintain (and be able to provide on request) updated documentation of your internal PV activities:

PV-training at MAH

The person responsible for pharmacovigilance activities at your organization must document that:

• They have read and understood the Guideline on good pharmacovigilance practices (GVP) modules in force (modules I, II and III, as a minimum)

• They have completed training in your pharmacovigilance SOPs

• They have completed the annual training on adverse event management (AE awareness training).
  

All your employees must know what to do if they receive safety information. Employees covered by the scope of your SOP on handling adverse events or other safety information must document that:

• They have completed the annual AE awareness training in adverse event management.

Training documentation should include SOP/document name and version number, employee name, date of training, and the employee’s signature.

Regular checks of adverse event report sources

You must document that you regularly check your email inboxes and other potential sources of safety information such as websites and social media for incoming adverse event reports and other safety information. Your PV provider can provide you with a template for documenting this.

Safety surveillance

As a marketing authorisation holder, you are legally required to retain oversight of the safety profile of your medicinal products. Your PV service provider can handle safety surveillance activities for your medicinal product. There are various ways to do this and various information sources to check. At PharmAdvice we document this in what we call periodic safety reports (PSRs), not to be confused with periodic safety update reports!

For the preparation of PSRs, your PV service provider will need some information from you, including:

• Amendments to the SmPC

• Sales data for each product (countries, strengths, pack sizes).

Your PV consultant will keep you informed of the due dates for safety surveillance and any input needed from you.

Periodic safety update reports (PSURs)

If you need to submit periodic safety update reports (PSURs) for your products, your pharmacovigilance consultant can prepare and submit these to the competent authorities in accordance with current standards and regulatory reporting timelines.

PSURs are prepared in close collaboration with you. You will be asked to provide information relevant to the report, and you will review the report before it is submitted to the competent authorities.

Your PV consultant will keep you informed of the due dates, any input needed, and the authorities’ assessment of the PSUR.